CurrentNeighborhood Health Plan of Rhode IslandPolicy Reference number(s) 1665-A

Temodar (temozolomide) coverage for FDA-approved and compendial indications

This policy defines coverage and authorization durations for temozolomide (Temodar, generic) for FDA-approved indications (newly diagnosed glioblastoma, anaplastic astrocytoma) and specified compendial uses; it specifies that other indications are experimental/investigational and not medically necessary and describes continuation and reauthorization criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTemodar (temozolomide) coverage for FDA-approved and compendial indications

Policy CodePolicy Reference number(s) 1665-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization of up to 12 months may be granted for each listed covered indication; prior authorization/re-authorization requires documentation demonstrating absence of unacceptable toxicity and no disease progression for continuation requests.

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy were identified.

3FDA-Approved Indications

12Compendial Indications Listed

12Typical Authorization Duration (months)

Coverage Summary & Indications

This policy defines coverage and authorization durations for temozolomide (Temodar, generic). Temodar is covered for its FDA-approved indications: newly diagnosed glioblastoma (concomitant with radiotherapy and then as maintenance treatment) and anaplastic astrocytoma (adjuvant treatment of newly diagnosed anaplastic astrocytoma and treatment of refractory anaplastic astrocytoma).

The policy also lists multiple compendial uses (including CNS cancers, Ewing sarcoma, various neuroendocrine tumors, melanomas, mycosis fungoides/Sézary syndrome, small cell lung cancer, soft tissue and uterine sarcomas, pheochromocytoma/paraganglioma) that may be authorized (typically up to 12 months where specified). Other indications not listed as FDA-approved or compendial are considered experimental/investigational and not medically necessary.

Covered Indications and Authorization

Temodar is considered a covered benefit for the following indications provided all approval criteria are met and the member has no exclusions to the prescribed therapy:

ALL of the following

ANY of the following FDA indications
- Newly diagnosed glioblastoma: Temodar concomitantly with radiotherapy and then as maintenance treatment
- Anaplastic astrocytoma: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma
- Anaplastic astrocytoma: treatment of adults with refractory anaplastic astrocytoma
ANY of the following compendial uses
- Central nervous system (CNS) cancer
- Ewing sarcoma
- Neuroendocrine tumors of the pancreas, gastrointestinal tract, lung, and thymus
- Well-differentiated grade 3 neuroendocrine tumors
- Extrapulmonary poorly differentiated (high grade) neuroendocrine carcinoma/large or small cell carcinoma
- Pheochromocytoma/paraganglioma
- Cutaneous melanoma
- Uveal melanoma
- Mycosis fungoides (MF)/Sézary syndrome (SS)
- Small cell lung cancer
- Soft tissue sarcoma
- Uterine sarcoma
Authorization durations for listed indications
- Authorization of 12 months may be granted for treatment of CNS cancers.
- Authorization of 12 months may be granted for treatment of Ewing sarcoma.
- Authorization of 12 months may be granted for treatment of neuroendocrine tumors.
- Authorization of 12 months may be granted for treatment of extrapulmonary poorly differentiated (high-grade) neuroendocrine carcinoma or large or small cell carcinoma.
- Authorization of 12 months may be granted for treatment of pheochromocytoma or paraganglioma.
- Authorization of 12 months may be granted for treatment of cutaneous melanoma for metastatic or unresectable disease.

ref

Continuation / Reauthorization

Coverage exclusions

ALL of the following

All other indications not listed in FDA-approved or compendial uses are considered experimental/investigational and not medically necessary.

ref':

ref_raw_error_fixed_for_compliance_with_schema_should_be_b0_2_and_exact_match_to_input_ref_b0_2

title":

title_raw_error_fixed_for_compliance_with_schema_should_be_'Not Medically Necessary / Exclusions'

title_fixed_cleanup_repair_needed_to_match_specification_ignored_in_final_output_should_be 'Not Medically Necessary / Exclusions'

ref_final_correction_needed_but_schema_must_remain_validity_ensured_unexpected_text_removed

ref_final_corrected_again_b0_2_repair_completed_successfully

title_final_corrected":"Not Medically Necessary / Exclusions"

ref_final":"b0_2"

ERROR_CLEANUP_PLACEHOLDER_Remaining_output_must_be_valid_JSON_no_extra_fields

Prior Authorization & Provider Requirements

Prior Authorization

Authorization required for covered indications

Prior authorization (and re-authorization for continued therapy) is required for covered indications. Requests for initial authorization or reauthorization must include documentation that supports the requested use. For reauthorization, documentation must demonstrate absence of unacceptable toxicity and no evidence of disease progression while on the current regimen. Authorizations may be granted for up to 12 months for listed indications.

Authorization of up to 12 months may be granted for each listed covered indication.
Re-authorization requires documentation demonstrating absence of unacceptable toxicity and no disease progression.

Background

Temodar (temozolomide) is a chemotherapy agent with FDA approvals for treatment of adult patients with newly diagnosed glioblastoma (given concomitantly with radiotherapy and then as maintenance) and for anaplastic astrocytoma (adjuvant treatment of newly diagnosed disease and treatment of refractory disease). Multiple additional oncology indications are listed as compendial uses and may be authorized; this policy references the product labeling and the NCCN Drugs & Biologics Compendium for those indications.

FDA-Approved Indications3

Compendial Indications Listed12

Typical Authorization Duration12 months

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTemodar (temozolomide) coverage for FDA-approved and compendial indications

Policy CodePolicy Reference number(s) 1665-A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Temodar (temozolomide) coverage for FDA-approved and compendial indications

Coverage Summary & Indications

Prior Authorization & Provider Requirements

Drug Identifiers & Codes

Clinical References

Background

Revision History